Associate Director, Sterility Assurance

The Role

The Associate
Director, Sterility Assurance / Environmental Monitoring (EM) is a senior technical role fully dedicated to the MTC-E facility. This individual is accountable for the design, implementation, and oversight of the site's Contamination Control Strategy (CCS) and Environmental Monitoring (EM) program, ensuring execution is aligned with regulatory expectations, operational needs, and best practices in aseptic manufacturing.

This is a high-impact, hands‑on role requiring regular presence on the manufacturing floor to observe, audit, and address behaviors, aseptic techniques, and process execution. The Associate Director partners closely with Manufacturing, MS&T, Facilities, QC, and Engineering, integrating sterility assurance into all layers of operations. This leader must be technically expert, data‑driven, and proactive in identifying risks and driving continuous improvement across the site.

• Contribute to the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with Annex 1, FDA aseptic guidance, and internal quality expectations.

• Ensure risk‑based, practical integration of CCS into isolator usage, cleanroom design, gowning, material/personnel flow, and environmental control.

• Lead key EM program lifecycle for MTC-E: sampling strategy, zoning, drawing management, alert/action levels, and trend reporting.

• Guide EM‑related root cause investigations, excursion management, and system improvements.

• Present EM performance and risk trends to site leadership and drive data‑based decision making.

• Own and author sterility assurance‑related Quality System documentation, including:

  • Change controls for EM, CCS, or aseptic practices

  • Risk assessments for sterility‑impacting changes or contamination events

  • CAPAs tied to EM deviations, audit findings, or trend analysis

• Ensure records are timely, scientifically justified, and aligned with site and global quality systems.

• Serve as a critical leader in audit preparation, defense, and follow‑up, including internal, client, and regulatory inspections.

• Act as SME for CCS, EM, aseptic execution, isolator operations, and media fills.

• Lead or support drafting of inspection responses and implementation of remediation strategies.

• Be actively present during key operations, including:

  • Media fills

  • Sterile filtration and aseptic filling operations

  • Isolator decontamination and validation events

  • Facility or process qualifications impacting sterility or EM

• Support real‑time issue resolution and verify proper execution of validated practices.

• Conduct routine floor audits to assess aseptic behaviors, gowning, EM technique, and adherence to contamination controls.

• Coach floor personnel and partner with QA to reinforce expectations and elevate sterile execution culture.

• Support aseptic training and certification programs site‑wide.

• Partner closely with Operations, Facilities, MS&T, QC, Engineering, and Supply Chain to proactively manage sterility assurance across all activities.

• Be available 24/7 to respond to contamination events, EM alerts, and operational escalations requiring sterility input.

• Education: Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or related field (Master’s or Ph.D. preferred).

• Experience:

  • 8+ years in sterile pharmaceutical manufacturing, aseptic processing, or sterility assurance roles

  • Deep expertise in isolator‑based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations

  • Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership

• Must be on‑site daily and available 24/7 per business needs for escalations and critical event support.

• Strong understanding of aseptic manufacturing, campaign operations, and support service…